Clinical TrialPostpartum DepressionEsketaminePlaceboActive not recruiting

Effect of Low-dose Esketamine on Maternal Depression at 2 Years After Childbirth

Double-blind, randomized, placebo-controlled follow-up (n=364) assessing whether a single immediate postpartum IV infusion of low-dose esketamine (0.2 mg/kg) reduces incidence of maternal depression at 2 years postpartum in women with prenatal depressive symptoms.

Target Enrollment
364 participants
Study Type
Phase IV interventional
Design
Randomized, quadruple Blind

Detailed Description

This is a 2-year follow-up of a multicentre randomized, double-blind, placebo-controlled trial that administered a single immediate postpartum IV infusion of low-dose esketamine (0.2 mg/kg in 20 ml saline over ~40 minutes) to women with prenatal depressive symptoms.

The primary aim is to evaluate the incidence of maternal depression two years after delivery; preliminary 42-day results suggested reduced incidence with esketamine.

Outcomes include diagnostic assessments of depression at follow-up, safety and adverse events, and child developmental considerations described in the protocol.

Study Protocol

Preparation

sessions

Dosing

1 sessions
40 min each

Integration

sessions

Study Arms & Interventions

Esketamine

experimental

Immediate postpartum intravenous infusion of low-dose esketamine (single infusion).

Interventions

  • Esketamine0.2 mg/kg
    via IV• single dose• 1 doses total

    0.2 mg/kg in 20 ml normal saline infused at 30 ml/h over ~40 minutes postpartum

Placebo

inactive

Immediate postpartum intravenous infusion of normal saline (single infusion).

Interventions

  • Placebo
    via IV• single dose• 1 doses total

    20 ml normal saline infused at 30 ml/h over ~40 minutes postpartum

Participants

Ages
18 – 99
Sexes
female

Inclusion Criteria

  • All 364 pregnant women who participated in the underlying trial "Effect of low-dose esketamine on the incidence of postpartum depression in women with prenatal depression: a randomized, double-blind, placebo-controlled trial" (NCT04414943) and agreed to accept this 2-year follow-up.
  • Inclusion criteria of the underlying trial:
  • Maternal age ≥18 years;
  • Prenatal Edinburgh postnatal depression scale score ≥10 points.

Exclusion Criteria

  • Exclusion criteria of the previous study:
  • A clear history of mental illness (depression, schizophrenia, etc.) or communication disorders;
  • Severe pregnancy complications (such as severe preeclampsia, placenta accreta, HELLP syndrome, placenta previa, placenta abruption) before surgery;
  • ASA grade ≥III;
  • The presence of contraindications to ketamine/esketamine use (e.g., refractory hypertension, severe cardiovascular disease [cardiac function grade ≥III], hyperthyroidism).

Study Details

  • Status
    Active not recruiting
  • Phase
    Phase IV
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment364 participants
  • Timeline
    Start: 2020-06-19
    End: 2024-11-30
  • Compounds
    EsketaminePlacebo
  • Topic
    Postpartum Depression

Locations

Hunan Provincial Maternal and Child Health Care Hospital — Changsha, Hunan, China
Women's Hospital of Nanjing Medical University — Nanjing, Jiangsu, China
Women's Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China
Peking University First Hospital — Beijing, China

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